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Health Condition(s) or Problem
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Liver Transplantation; Mycoses
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Lay Summary
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Prevention of invasive fungal infection in high risk patients following liver transplant.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Undergoing orthotopic whole or split liver allograft transplantation
- Patients at 'high risk' of invasive fungal infection due to the presence of at least
one of the following risk factors:
- Re-transplantation
- Acute liver failure
- Pre- or post-operative renal impairment (defined as creatinine clearance =40
ml/min) or need for renal replacement therapy
- Admission to Intensive Care Unit (ICU) for greater than 48 hours prior to liver
transplant
- Re-operation (abdominal surgery) within 5 days of liver transplant
- Presence of choledocojejunostomy
- Perioperative colonization with fungi, defined as two or more positive clinical
site surveillance cultures for Candida spp., obtained within 96 hours before or
after liver transplant
- Need for prolonged mechanical ventilation for greater than 48 hours following
liver transplant
- Transfusion intraoperatively of 20 or more units of cellular blood products
- Female subject of childbearing potential must have a negative urine or serum
pregnancy test prior to randomization and must agree to maintain effective birth
control during the study
Exclusion Criteria:
- Any systemic antifungal therapy (excluding fluconazole or oral nystatin for a maximum
of 7 days) within 14 days prior to randomization
- Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD
(according to the EORTC/MSG criteria)
- Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or
any of the study drugs or their excipients
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Who cannot enter the trial
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Inclusion Criteria:
- Undergoing orthotopic whole or split liver allograft transplantation
- Patients at 'high risk' of invasive fungal infection due to the presence of at least
one of the following risk factors:
- Re-transplantation
- Acute liver failure
- Pre- or post-operative renal impairment (defined as creatinine clearance =40
ml/min) or need for renal replacement therapy
- Admission to Intensive Care Unit (ICU) for greater than 48 hours prior to liver
transplant
- Re-operation (abdominal surgery) within 5 days of liver transplant
- Presence of choledocojejunostomy
- Perioperative colonization with fungi, defined as two or more positive clinical
site surveillance cultures for Candida spp., obtained within 96 hours before or
after liver transplant
- Need for prolonged mechanical ventilation for greater than 48 hours following
liver transplant
- Transfusion intraoperatively of 20 or more units of cellular blood products
- Female subject of childbearing potential must have a negative urine or serum
pregnancy test prior to randomization and must agree to maintain effective birth
control during the study
Exclusion Criteria:
- Any systemic antifungal therapy (excluding fluconazole or oral nystatin for a maximum
of 7 days) within 14 days prior to randomization
- Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD
(according to the EORTC/MSG criteria)
- Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or
any of the study drugs or their excipients
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What will happen
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Drug; micafungin; intravenous infusion; micafungin; Mycamine; Drug; fluconazole; intravenous infusion; standard care; Diflucan; Drug; liposomal amphotericin B; intravenous infusion; standard care; AmBisome; Drug; caspofungin; intravenous infusion; standard care; Cancidas
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Primary aim
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'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
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Secondary Aim
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Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB; 3 months; No; Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator; up to 21 days & 3 months; No; Time to 'proven' or 'probable' IFD; up to 3 months; No; Fungal free survival at the End of Study and at the end of Long-term Follow-up; 3 months & 6 months; No; Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline; up to 21 days; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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England
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Location
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Birmingham, London
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